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Five Considerations When Choosing a Package Testing Laboratory

August 1, 2013 2:22 pm | by Mike Woletz, CPP, Senior Project Manager, DDL Inc. | Comments

While options may be limited overall, selecting the right package testing laboratory can still be critical for a medical device manufacturer to ensure a timely and on-budget product launch. Therefore, keeping the following five considerations in mind when going through the selection process can make a significant impact on a company’s success.

Micro Molding: Reduce the Cost to Manufacture a Medical Device

July 31, 2013 3:28 pm | by John Whynott, Technical Product Manager, Mikrotech, LLC | Mikrotech | Comments

Micro molding can provide an excellent alternative for designing and manufacturing medical devices used in minimally invasive surgery. Micro manufacturing processes overcome the limitations of established technologies, facilitating smaller components, incorporating complex features, reducing the number of components, eliminating outdated processes, reducing manufacturing costs, and increasing production yields.

Making Old ‘New’ Again: Prioritizing Medical Device Features Using Kano Model Analysis

July 30, 2013 4:29 pm | by Jemma Lampkin and Gerard Loosschilder, SKIM Inc. | Comments

Medical device product development teams are often asked to develop new features for new devices or updated generations of existing devices. Often, due to cost or resource restrictions, a decision needs to be made between including one feature versus another.

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Bringing Wi-Fi to Healthcare

July 29, 2013 10:54 am | by Joe Zeto, Director of Product Marketing for Ixia | Comments

Today’s medical staffs increasingly rely upon wireless networks and devices to conduct critical-care applications, access electronic medical records and test results, and to share information throughout facilities. At the same time, Wi-Fi networks in healthcare facilities are being pushed to the limits by the Bring Your Own Device (BYOD) trend among patients and guests.

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Medical Device Security—Beyond the Password

July 24, 2013 3:21 pm | by Alan Grau, President and Cofounder, Icon Labs | Comments

The FDA and Department of Homeland Security recently issued an alert urging medical device makers and medical facilities to upgrade security protections to protect against potential cyber threats. This came in response to an ICS-CERT publication of a list of more than 300 devices with hard coded passwords.

Equipment Financing Offers Flexible Solutions for the Medical Device Industry

July 24, 2013 2:47 pm | by William G. Sutton, CAE, President and CEO, Equipment Leasing and Finance Association | Comments

Acquiring equipment through leasing and other financing methods is more flexible and customizable to meet unique business needs than most funding options. This makes medical equipment finance a perfect fit, especially for start-up and small businesses, which may have trouble getting traditional bank loans.

Best Practices for and Common Pitfalls in Creating Device Listing Files

July 24, 2013 2:32 pm | by Howard Shatz, SPL and ACA 6004 Project Manager, Data Conversion Laboratory | Comments

Since June 2009, all drug listing submissions have been done electronically using Structured Product Labeling (SPL) files. Now, devices can be listed using SPL as well. While the FDA does not require that devices be listed using SPL, the ability to do is there, with benefits including providing product exposure on sites such as the National of Library of Medicine’s (NLM) DailyMed.

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Renew Focus on Quality in Medical Device Manufacturing

July 23, 2013 4:34 pm | by James Pink, Partner, NSF Medical Devices, Part of NSF International’s Health Sciences Division | Comments

While regulators are understandably focused on compliance, industry needs to focus on quality. The terms are often used interchangeably, but there’s a big difference between quality and compliance. Think of quality as the processes, procedures, and culture that permeate an organization—enabling it to consistently develop and produce high-quality medical device products that will meet or exceed regulatory requirements.

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IEC 60601-2-34 Issue 3: Changes to Recovery Test

July 22, 2013 2:11 pm | by Jeff Lind, CEO & Jose Cabanillas, Hardware Engineer, Compliance West USA | Compliance West USA | Comments

The IEC has made a change to the Recovery Test, 60601-2-34. Issue 3 offers modifications that make it more beneficial for engineers as a custom test system is no longer required for this specific test. This article reviews the full breadth of the test and how it can impact medical device manufacturers.

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Quality Control Compass for Leak Testing in Flexible Manufacturing

July 18, 2013 2:14 pm | by Jacques Hoffmann, President, InterTech Development Company | Intertech Development Company | Comments

As flexible manufacturing becomes a more attractive option to medical device manufacturers, ensuring that the processes involved with it all work in sync is critical. With leak testing in this system, there are a number of factors that need to be considered. This article reviews the areas that engineers need to keep in mind when adapting to this option.

Medical Device Testing’s Requirement for Axial-Torsion Loading Regimes

July 18, 2013 12:47 pm | by Vincent Milano, Biomedical Account Director, ADMET | Admet, Inc. | Comments

Medical device engineers rely on an array of testing instruments and equipment to verify the safety and efficacy of their products. An axial-torsion testing system is just one of them; however, it has a variety of indications across various device sectors. This article looks at two products for which this testing instrument is invaluable.

Using Notebook Studies to Help Ensure a Successful Reusable Device Cleaning Validation

July 16, 2013 2:34 pm | by Patrick Kenny, Director of Analytical Services, Microtest Laboratories | Microtest Laboratories, Inc. | Comments

Device manufacturers need to ensure their product will be sufficiently cleaned by healthcare professionals. This article will focus on the areas of the FDA’s guidance document that are causing difficulties in cleaning validations, and will demonstrate how pre-validation laboratory work can help save time and money.

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Ensuring the Right Fit: Medical Device Testing and the Human Factor

July 16, 2013 2:12 pm | by Chris Evans, Director of Innovation—Pharmaceutical Delivery Systems, West Pharmaceutical Services | West Pharmaceutical Services, Inc. | Comments

Device testing is required for a wide array of variables in the development of a medical device. When it comes to devices used directly by the patient, however, it is critical to test the patient/device “relationship.” This article looks at examining and testing the human factor when it comes to the handling of a medical device and how the design can be improved to enhance that relationship.

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The Power of LEDs Inside Medical Devices

July 15, 2013 3:12 pm | by Chuck DeMilo, Global Director of Product Marketing, Lighting Business Group, Luminus Devices | Comments

The medical device industry is constantly changing. New technologies and products enter the market, replacing outdated or inefficient equipment. There are numerous benefits in using LEDs for medical illumination applications including longer life, less heat, dynamic control, lower energy consumption, and in many cases, lower cost.

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Designing for the Critical Care Environment

July 12, 2013 2:49 pm | by Barry Crane, Chief Technical Officer, GlySure Limited | Comments

Critically ill patients present a number of challenges to effective monitoring. Various disease states complicate blood chemistry, compromise perfusion, and cause fluctuating blood pressure levels, heart rates, body temperatures, available oxygen, and pH. Furthermore, the pharmaceuticals used to treat these conditions can skew body chemistry and vital signs, adding to the complexity.

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